GSK's marketing application for linerixibat, targeting cholestatic pruritus in PBC patients, gains EMA acceptance based on phase III success.

GSK (GSK) plc announced that the U.S. Food and Drug Administration has approved a 200 mg/mL autoinjector of Benlysta, a B-lymphocyte ...

EMA accepts GSK’s MAA for linerixibat for cholestatic pruritus in patients with primary biliary cholangitis: London, UK Tuesday, June 24, 2025, 09:00 Hrs [IST] GSK plc announced ...

The EMA has started a review of GSK's treatment candidate for primary biliary cholangitis (PBC), linerixibat, offering hope ...

GSK said on Monday that the European Medicines Agency has accepted its marketing authorisation application for linerixibat, an investigational treatment for cholestatic pruritus in patients with ...

THIS YEAR, the vibrant city of Amsterdam, the Netherlands played host to the European Association for the Study of ...

The FDA has accepted for review the NDA for linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.

GSK (LSE:GSK) announced that the European Medicines Agency accepted its regulatory application to expand the use of its RSV ...

Linerixibat also significantly reduced itch-related sleep interference, with an LS mean difference of -0.53 (p=0.024). Fifty-six percent of patients treated with linerixibat achieved a clinically ...

If approved, linerixibat could address an area of high unmet medical need for patients living with cholestatic pruritus and related sleep interference. Year to date, shares of GSK have rallied 23. ...

Linerixibat was also associated with significant improvements in key secondary endpoints vs placebo, including itch score at week 2 (P <.001) and itch-related sleep interference over 24 weeks (P ...